FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75721–75744 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2002
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
K020254 · LCM
Lin-Zhi International, Inc.
Toxicology · 106d
Cleared May 10, 2002
THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
K020445 · GXY
The Electrode Store, Inc.
Neurology · 88d
Cleared May 10, 2002
CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM
K020449 · LLZ
Cardionow, Inc.
Radiology · 88d
Cleared May 10, 2002
PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER
K020453 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 88d
Cleared May 10, 2002
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
K020617 · DZE
Nsi
Dental · 74d
Cleared May 10, 2002
EMIT 2000 VANCOMYCIN ASSAY
K020692 · LEH
Dade Behring, Inc.
Toxicology · 67d
Cleared May 10, 2002
SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM...
K020719 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 66d
Cleared May 10, 2002
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031...
K020763 · DIO
Lin-Zhi International, Inc.
Toxicology · 64d
Cleared May 10, 2002
FORTAFLEX SURGICAL MESH
K021105 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 35d
Cleared May 10, 2002
OCTEIA 25-HYDROXY VITAMIN D
K021163 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 29d
Cleared May 10, 2002
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
K021258 · MCF
Germ Terminator Corporation
Dental · 21d
Cleared May 10, 2002
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
K021413 · ELW
Dentsply Intl.
Dental · 7d
Cleared May 09, 2002
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
K012132 · NIC
Cantor & Nissel , Ltd.
Ophthalmic · 304d
Cleared May 09, 2002
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
K013053 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 240d
Cleared May 09, 2002
MICROJET CRONO H
K013855 · FRN
Cane S.R.I.
General Hospital · 170d
Cleared May 09, 2002
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
K020430 · NFK
Diatek, Inc.
Gastroenterology & Urology · 90d
Cleared May 09, 2002
INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K020535 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 79d
Cleared May 09, 2002
OHMEDA MEDICAL GIRAFFE OMNIBED
K020543 · FMZ
Ohmeda Medical
General Hospital · 79d
Cleared May 09, 2002
OHMEDA MEDICAL GIRAFFE INCUBATOR
K020547 · FMZ
Ohmeda Medical
General Hospital · 79d
Cleared May 09, 2002
SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
K020561 · IYO
Tomtec Imaging Systems GmbH
Radiology · 78d
Cleared May 09, 2002
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
K020566 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 78d
Cleared May 09, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K020709 · KWP
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared May 09, 2002
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
K020724 · MRR
Dade Behring, Inc.
Chemistry · 64d
Cleared May 09, 2002
GATIFLOXIN
K020762 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d